Articles related to CLINICAL TRIALS

The phase 2 L-MIND trial presented at the AACR 2023 conference showed that tafasitamab plus lenalidomide and tafasitamab maintenance resulted in durable responses for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The trial treated patients with DLBCL who were not eligible for an autologous stem cell transplant with tafasitamab plus lenalidomide for 12 cycles, followed by tafasitamab alone until disease progression. With a median of 44 months of follow-up for the entire cohort, the objective response rate (ORR) was 57.5%. The ORR was higher among patients who had received only one prior line of therapy at 67.5%, whereas 47.5% of patients who had received multiple prior lines of treatment experienced a response. The complete response rate was 41.3% overall, with the median duration of response (DOR) not reached in all cohorts. The median progression-free survival (PFS) was 11.6 months for the entire cohort, while the median PFS of the cohort with one prior line of therapy was 23.5 months, whereas patients with multiple prior lines of therapy demonstrated a median PFS of 7.6 months. The frequency of treatment-emergent adverse events (TEAEs) decreased over time, and diarrhea and peripheral edema were the most common TEAEs during the initial treatment period […]

As reported at the at the AACR Annual Meeting 2023, the combination of Ianalumab and ibrutinib showed promising results in treating chronic lymphocytic leukemia (CLL) in a phase 1b, dose-escalation and expansion trial. Ianalumab, an anti-BAFF-R monoclonal antibody, works by inhibiting B-cell differentiation, proliferation, and survival, and depleting B-cells through antibody-dependent cellular cytotoxicity within the tumor microenvironment. The trial treated 15 patients with CLL who were already receiving ibrutinib with different doses of Ianalumab for 6 cycles, with patients continuing the combination up to cycle 8 if they showed evidence of disease, and then followed up every 3 months for 2 years. The ORR at cycle 9 or before treatment discontinuation was 56.7%, with a complete response (CR) rate of 37.8%. Patients who were in their first line of treatment showed better outcomes than patients who had relapsed or refractory disease, with the ORR for previously-untreated patients being 81.8% with a CR of 54.5% and a CR + CRi of 63.6%. Additionally, 45.9% of patients achieved undetectable minimal residual disease (uMRD) in blood or bone marrow by cycle 9 of treatment, including 63.6% of patients in their first line of therapy and 38.5% of patients with relapsed/refractory disease. There were […]

The approval was based on results from a 24-week open-label, two-part phase 3 trial that assessed Trikafta’s effectiveness and safety in 75 CF patients having at least one F508del mutation or a mutation known to be responsive to Trikafta. According to the findings, patients’ sweat chloride concentration and lung clearance index decreased in a clinically significant way. Trikafta therapy was typically well tolerated and commensurate with results seen in individuals who were older.

In patients with R/R MDS/AML, the combination ipilimumab + decitabine (IPI + DEC) therapy shows a favorable safety profile and significant therapeutic activity that doesn’t seem to require T cell-mediated alloreactivity. Potential transplant candidates may find that IPI + DEC therapy acts as a less strenuous transition to transplant. Future research is necessary to determine logical IPI-based treatment plans that can provide persistent responses without causing significant immune damage.

In a study of 256,288 individuals who tested positive for COVID-19 and had at least one risk factor for developing severe COVID, regardless of immunization, booster, or prior infection history, treatment with nirmatrelvir reduced rates of hospital admission or death at 30 days.

In a study originally published in Multiple Sclerosis and Related Disorders, alemtuzumab infusion resulted in significantly improved MS-COG scores in the patients evaluated after 12 months, with scores improving from an initial mean of -0.36, to 0.61.